From the Guidelines
The Affirm Vaginitis diagnostic test covers the detection of bacterial vaginosis, vulvovaginal candidiasis (yeast infection), and trichomoniasis, specifically identifying Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis. The test is designed to detect these pathogens from a single vaginal swab sample, providing more accurate results than traditional methods like microscopy or culture 1. The pathogens covered by the Affirm test include:
- Bacterial vaginosis: Gardnerella vaginalis
- Yeast vaginitis: Candida albicans
- Trichomoniasis: Trichomonas vaginalis The Affirm VP III Assay is FDA-cleared for vaginal specimens from symptomatic female patients only and does not rely on viable organisms for optimal test performance 1. Early and accurate diagnosis through this comprehensive test allows for appropriate targeted therapy, reducing the risk of complications and recurrent infections. The test's ability to detect these specific pathogens enables healthcare providers to prescribe the correct treatment, such as antibiotics for bacterial vaginosis, antifungal medications for yeast infections, and antiprotozoal treatment for trichomoniasis. It is essential to note that the Affirm test has limitations, including lower sensitivity for Trichomonas vaginalis compared to nucleic acid amplification tests (NAATs) 1. However, the test remains a valuable tool for diagnosing and managing vaginitis in clinical practice. The use of the Affirm test can help improve patient outcomes by providing accurate and timely diagnosis, allowing for targeted treatment and reducing the risk of complications and recurrent infections 1.
From the FDA Drug Label
The following in vitro data are available, but their clinical significance is unknown Tinidazole is active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis: Bacteroides spp. Gardnerella vaginalis Prevotella spp. Tinidazole demonstrates activity both in vitro and in clinical infections against the following protozoa: Trichomonas vaginalis; Giardia duodenalis (also termed G. lamblia); and Entamoeba histolytica.
The Affirm Vaginitis diagnostic test is not mentioned in the provided drug labels. However, based on the information provided about the treatment of vaginitis, the pathogens that may be associated with vaginitis include:
- Bacterial vaginosis: Bacteroides spp., Gardnerella vaginalis, Prevotella spp.
- Protozoal infections: Trichomonas vaginalis, Giardia duodenalis, Entamoeba histolytica
- Other pathogens that should be ruled out: Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, Herpes simplex virus [2] [3]
From the Research
Pathogens Covered by Affirm VPIII
The Affirm VPIII diagnostic test covers the following pathogens for vaginitis:
- Gardnerella vaginalis
- Candida species
- Trichomonas vaginalis
Detection and Identification
The Affirm VPIII test is a more sensitive diagnostic test for detection and identification of these pathogens compared to conventional clinical examination and wet mount testing 4, 5, 6. The test can detect clinically significant levels of G. vaginalis, Candida spp., and T. vaginalis 5. The sensitivity and specificity of the Affirm test for Gardnerella and Candida were found to be significant compared to diagnostic standards 7.
Comparison with Other Diagnostic Methods
The Affirm VPIII test correlated well with wet mount, Gram stain, and mycological culture 5. The test was also compared to the Papanicolaou (Pap) test, and the results demonstrated that the Affirm VPIII was a more sensitive diagnostic test for the detection and identification of the three organisms 6. The Affirm test can be used to detect G. vaginalis, C. albicans, and T. vaginalis microbial infections in Korean women, with significant sensitivity and specificity compared to diagnostic standards 7.